Evalve Inc & Ors v Edwards Lifesciences Ltd

Under the Disclosure Pilot Rules, disclosure must be directed to a pleaded key issue that requires contemporaneous documents for a fair resolution. Material which would matter only if the court were independently assessing the objective superiority of competing medical devices is irrelevant where the pleaded case concerns clinicians’ reasonable clinical judgments. Adverse-event reports viewed in isolation cannot reliably establish the significance of those events to that issue. An application for extended disclosure may therefore be refused because the material does not concern an issue for disclosure. In any event, disclosure must be reasonable and proportionate having regard to the overriding objective.

The claimants alleged that the defendant’s PASCAL mitral-valve repair device infringed two patents. The defendant denied infringement and validity, and pleaded a public-interest defence to a possible permanent injunction under section 50 of the Senior Courts Act 1981. The defence relied on clinicians’ preference for PASCAL because of its perceived clinical advantages.

The claimants sought specific disclosure of documents recording adverse events involving PASCAL, including abandoned procedures and subsequent or additional MitraClip implantation. The application was initially made under CPR 31.12, but the claimants accepted that the Disclosure Pilot Rules applied. The central issue was whether the requested material fell within the pilot’s definition of an issue for disclosure and, if so, satisfied the requirements for extended disclosure.

1. Applicable regime. The application was governed by the Disclosure Pilot Rules rather than CPR 31.12. The parties’ concessions correctly identified the procedural framework.
2. Meaning of the pleaded defence. The public-interest defence was read conjunctively. Its central case was that clinicians, exercising reasonable clinical judgment, might prefer PASCAL because it could treat patients who could not otherwise be treated successfully or might provide a more favourable clinical outcome. The court was not required to decide whether that case would ultimately establish the defence.
3. Scope of the evidence. The issue was clinicians’ reasonable judgment, not a court-conducted, objective assessment of product superiority from first principles. The defendant’s evidence addressed that pleaded issue. Adverse-event reports not seen by clinicians would not enable sensible conclusions to be drawn when considered in isolation or without clinical context. They were therefore irrelevant to the issues requiring disclosure.
4. Disclosure Pilot Rules. Paragraph 7(3) limits issues for disclosure to key issues in dispute which the parties consider will need determination by reference to contemporaneous documents for a fair resolution. The requested material did not satisfy that definition, so the application failed on that ground. If it had been relevant, paragraph 6(4) would still have required extended disclosure to be reasonable and proportionate having regard to the overriding objective; the judge indicated that the requested disclosure would not satisfy that requirement even if it bore tangentially on an issue for disclosure.
5. Result. The application for specific disclosure was dismissed.